MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering. (MAC-SEE)
MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering (MAC SEE).
The study of calcifications involving the mitral valve is extremely important for the planning of both surgical and percutaneous procedures. Computed tomography (CT) is the non-invasive imaging modality considered the gold standard for the assessment of mitral valve calcifications, thanks to its high spatial resolution and the strong X-ray attenuation of calcium deposits.
Echocardiography has traditionally played a limited role in the evaluation of mitral valve calcifications, particularly with three-dimensional imaging. Three-dimensional transesophageal echocardiographic rendering with TrueVue transillumination (Philips Medical Systems, Eindhoven, NL) can provide additional information on the location and extent of calcium on the mitral valve by allowing the placement of a virtual light source beneath the mitral valve.
Specifically, the TrueVue system is an advanced software module integrated into Philips echographic equipment that uses data acquired by the transesophageal probe to generate photorealistic images of the heart.
Therefore, the ability to evaluate the position and extent of calcifications through transesophageal echocardiography may represent an important step forward for echocardiographic imaging.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
This is a non-profit, observational, bidirectional (prospective and retrospective), multicenter study aimed at comparing the diagnostic accuracy of the following modalities:
- Contrast-enhanced computed tomography (CT) (gold standard)
- Three-dimensional transesophageal echocardiography
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Gianluca Pontone, MD
- Telefonnummer: +39 0258002574
- E-Mail: gianluca.pontone@cardiologicomonzino.it
Studienorte
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Milan
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Milan, Milan, Italien, 20138
- Rekrutierung
- Centro Cardiologico Monzino; IRCCS
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Kontakt:
- Chiara Centenaro, 025800203
- Telefonnummer: +39 0258002031
- E-Mail: chiara.centenaro@cardiologicomonzino.it
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria
Retrospective Cohort
- Have already undergone, between February 2025 and September 2025, a contrast-enhanced CT scan and a transesophageal echocardiogram.
- Are ≥ 18 years old.
Prospective Cohort
- Are scheduled to undergo a contrast-enhanced CT scan and a three-dimensional transesophageal echocardiogram as part of their routine clinical assessment for their underlying cardiac condition, with or without mitral annular or leaflet calcifications.
- Are ≥ 18 years old
- who have provided written informed consent to participate in the study
Exclusion Criteria:
Retrospective Cohort
- The following patients will be considered not eligible:
- Patients younger than 18 years.
- Patients whose data are incomplete for the purposes of the planned study assessments
- Patients who have explicitly refused the use of their data for research purposes.
Prospective Cohort
- Patients younger than 18 years.
- Patients who have not signed the study Informed Consent Form
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Prospective Cohort
In the prospective part of the study, adult patients who, for any clinical indication and as part of routine clinical care, are scheduled to undergo both contrast-enhanced chest computed tomography (CT) and three-dimensional transesophageal echocardiography (3D TEE) will be consecutively enrolled. As this is an observational study, participants will not undergo any additional diagnostic procedures or receive any additional treatments beyond standard clinical practice. Data will be collected from examinations performed according to routine care. |
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Retrospective Cohort
In the retrospective part of the study, clinical and imaging data will be collected from adult patients who have already undergone both contrast-enhanced chest computed tomography (CT) and three-dimensional transesophageal echocardiography (3D TEE) as part of routine clinical care. Eligible examinations performed between February 2025 and September 2025 will be reviewed. Only patients with complete data required for the study analyses will be included. No additional procedures or interventions will be performed, as the study is observational and based exclusively on existing clinical records. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Quantification of Mitral Calcifications
Zeitfenster: 06/2026
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Diagnostic accuracy in the quantification of mitral calcifications, assessed through qualitative visual evaluation and defined by the presence of calcium involving: (1) the mitral valve; (2) the mitral annulus, with or without differentiation of the mitral scallops; and (3) the mitral leaflets, with or without differentiation of the mitral scallops.
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06/2026
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Semiquantitative assessment of mitral calcifications
Zeitfenster: 06/2026
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Diagnostic accuracy in the semiquantitative assessment of mitral calcifications through calculation of the "Mitral Annular Calcification Score."
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06/2026
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- L2-438
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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